Brief Digital Intervention to Increase COVID-19 Vaccination Among Individuals With Anxiety or Depression

NCT06119854 | Completed Results

• 1 other identifier: RF1MH132360
• Study Type: interventional
• Target: 1,419
• Locations: 1 country
• Sites: 1

Brief Summary

The COVID-19 pandemic has led to a mis/disinformation ecosystem that promotes divergent views of vaccine efficacy, as well as the legitimacy of science and medicine. Individuals are confronted with vaccine-related information from a multitude of sources, posing a challenge to identifying inaccurate information. COVID-19 vaccine uptake is lower among people with anxiety and depression than in the general population, due in part to higher levels of vaccine hesitancy. The prevalence of anxiety and depressive symptoms among US adults increased significantly during the COVID pandemic and has remained elevated. Interventions capable of mitigating the impact of vaccine hesitancy and mis/disinformation among undervaccinated people with anxiety or depression are therefore an urgent priority. Emerging evidence suggests that reasons for vaccine hesitancy and the impact of conventional vaccination messaging differ between those with and without mental health symptoms. There may also be added challenges overcoming logistical barriers to vaccination for people with anxiety or depressive symptoms. The investigators aim to determine the effectiveness of two different brief digital intervention strategies compared with conventional public health messaging for increasing vaccine uptake in undervaccinated adults with and without anxiety or depressive symptoms. Attitudinal inoculation is a brief, scalable strategy that leverages the power of narrative, values, and emotion to strengthen resistance to mis/disinformation and reduce hesitancy. Though this approach has been shown to decrease COVID-19 vaccine hesitancy among US adults, the extent to which this approach increases COVID-19 vaccination remains unknown. Cognitive-behavioral therapy (CBT) is an evidence-based intervention for anxiety and depression. However, the efficacy of incorporating CBT-informed messaging in a vaccine promotion intervention has not been tested. The investigators hypothesize that both attitudinal inoculation and CBT-style communication will be more effective than conventional public health messaging to increase COVID-19 vaccination. The investigators also hypothesize that the CBT-informed intervention will be more effective than the attitudinal inoculation intervention for increasing COVID-19 vaccination among participants with symptoms of anxiety or depression.

Conditions

Misinformation; Vaccine Hesitancy; Anxiety; Depression; COVID-19

Keywords

Anxiety; Depression; Vaccination; COVID-19

Outcome Measures

Primary Outcomes (1)

• Self-reported Receipt of COVID Vaccine Dose by 4 Weeks Post-intervention

  Following our theoretical premise that our intervention will impact the uptake of COVID-19 vaccination, the investigators define our primary outcome as self-reported receipt of a COVID vaccine dose in the 4 weeks post-intervention. Risk ratios will be used to estimate and compare the proportion of participants in each arm who achieved the outcome. The investigators will adjust for differences in measured pre-baseline variables to address potential imbalances and conduct a mediation analysis to better understand the intervention's mechanisms of action.

  4 weeks post-intervention

Secondary Outcomes (4)

• Participants Classified as Vaccine Willing

  4 weeks post-intervention

• Self-reported Receipt of a COVID Vaccine Dose by 6 Months Post-intervention

  6 months post-intervention

• Vaccine Willingness Post-intervention

  6-months post-intervention

• Vaccine Willingness Post-intervention

  immediately post-intervention

Study Arms (3)

Attitudinal inoculation intervention

EXPERIMENTAL

Participants randomized to this arm will view a brief video addressing one anti-vaccine "meta-narrative" or issue (e.g., concerns about the vaccine not working) most salient to the entire CHASING COVID study population (per recent historical data) and focused on bolstering resistance to mis/disinformation.

Behavioral: Attitudinal inoculation

Cognitive behavioral therapy-informed intervention

EXPERIMENTAL

Participants randomized to this arm will view a brief video using a CBT-informed approach and focused on addressing barriers to vaccination, with no inoculation messaging.

Behavioral: Cognitive-behavioral therapy-informed intervention

Conventional public health messaging

ACTIVE COMPARATOR

Participants randomized to this arm will view a brief video conveying conventional public health messaging adapted from a review of public health public service announcements, with no inoculation or CBT-informed messaging.

Behavioral: Conventional public health messaging

Interventions

Attitudinal inoculation BEHAVIORAL

A brief video focused on bolstering resistance to mis/disinformation about the COVID vaccine. Participants will receive two messages via text or email (1 and 3 days after the inoculation intervention). These messages will include reminders to get vaccinated.

Attitudinal inoculation intervention

Cognitive-behavioral therapy-informed intervention BEHAVIORAL

A brief video using a CBT-informed approach and focused on addressing barriers to COVID-19 vaccination. Participants will receive two messages via text or email (1 and 3 days after the inoculation intervention). These messages will include reminders to get vaccinated.

Cognitive behavioral therapy-informed intervention

Conventional public health messaging BEHAVIORAL

A brief video conveying conventional public health messaging adapted from a review of public health public service announcements with no inoculation messaging. Participants will receive two messages via text or email (1 and 3 days after the inoculation intervention). These messages will include reminders to get vaccinated.

Conventional public health messaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recently engaged in the CHASING COVID Cohort study (i.e., started ≥ 1 survey since December 7, 2022)
• Last COVID-19 vaccine dose prior to September 11, 2023
• Current residence in the US or a US territory
• Comprehension of written English

You may not qualify if:

• No dose of a COVID-19 vaccine
• Had a SARS-CoV-2 infection in the past 3 months

Sponsors & Collaborators

• City University of New York, School of Public Health: lead
• University of North Carolina, Chapel Hill: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

CUNY Graduate School of Public Health & Health Policy

New York, New York, 10027, United States

Location

Related Publications (4)

• Piltch-Loeb R, Su M, Hughes B, Testa M, Goldberg B, Braddock K, Miller-Idriss C, Maturo V, Savoia E. Testing the Efficacy of Attitudinal Inoculation Videos to Enhance COVID-19 Vaccine Acceptance: Quasi-Experimental Intervention Trial. JMIR Public Health Surveill. 2022 Jun 20;8(6):e34615. doi: 10.2196/34615.

  PMID: 35483050 BACKGROUND

• Robertson MM, Kulkarni SG, Rane M, Kochhar S, Berry A, Chang M, Mirzayi C, You W, Maroko A, Zimba R, Westmoreland D, Grov C, Parcesepe AM, Waldron L, Nash D; CHASING COVID Cohort Study Team. Cohort profile: a national, community-based prospective cohort study of SARS-CoV-2 pandemic outcomes in the USA-the CHASING COVID Cohort study. BMJ Open. 2021 Sep 21;11(9):e048778. doi: 10.1136/bmjopen-2021-048778.

  PMID: 34548354 BACKGROUND

• Parcesepe AM, Robertson M, Berry A, Maroko A, Zimba R, Grov C, Westmoreland D, Kulkarni S, Rane M, Salgado-You W, Mirzayi C, Waldron L, Nash D. The relationship between anxiety, health, and potential stressors among adults in the United States during the COVID-19 pandemic. medRxiv [Preprint]. 2020 Nov 4:2020.10.30.20221440. doi: 10.1101/2020.10.30.20221440.

  PMID: 33173880 BACKGROUND

• Piltch-Loeb R, Shen Y, Fleary S, Robertson M, Nunez Sahr J, Penrose K, Sanborn J, Yadav S, Srivastava A, Nash D, Parcesepe A. Testing Theory-Enhanced Messaging to Promote COVID-19 Vaccination Among Adults: Randomized Controlled Trial. J Med Internet Res. 2025 Oct 7;27:e79228. doi: 10.2196/79228.

  PMID: 41057045 DERIVED

MeSH Terms

Conditions

Communication; Vaccination Hesitancy; Anxiety Disorders; Depression; COVID-19

Condition Hierarchy (Ancestors)

Behavior; Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Mental Disorders; Behavioral Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

The study was conducted during a period of low COVID-19 activity, which may have reduced vaccine uptake. The brief video interventions may have limited impact, and participants were not required to watch them in full. Conducted late in the pandemic, findings may not generalize to earlier periods or future contexts. Follow-up is planned to assess longer-term effects.

Results Point of Contact

• Title: Denis Nash
• Organization: CityUNYSPH

denis.nash@sph.cuny.edu

3473316554

Study Officials

• Denis Nash, PhD

  CUNY Institute for Implementation Science in Population Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The investigators will assign undervaccinated cohort participants, with and without symptoms of anxiety or depression, to: 1) an attitudinal inoculation intervention; 2), a CBT-informed intervention; or 3) a conventional public health messaging intervention. Participants will be randomly assigned to one of the three intervention arms at a ratio of 1:1:1. Each arm will also be stratified 1:1 by presence or absence of anxiety or depression symptoms. Masking of participants to study arm assignment is not feasible due to the nature of the interventions. However, data collection analysts, study staff, and investigators will be masked to study arm assignments until analyses are complete.

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 7, 2023
• Study Start: April 15, 2024
• Primary Completion: June 13, 2024
• Study Completion: November 15, 2024
• Last Updated: September 11, 2025
• Results First Posted: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)